(132 days)
No
The document describes a mechanical bone screw and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a bone screw used for fracture fixation and is an orthopedic implant, not a therapeutic device in the sense of actively treating or healing a condition beyond providing mechanical support for healing.
No
Explanation: The device is a surgical implant (screws and washers) used for fracture fixation, not for diagnosing medical conditions. Its intended use is to treat bone fractures and injuries.
No
The device description clearly states that the device is a physical screw and optional washer made from titanium alloy, intended for bone fracture fixation. It does not describe any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The DARCO® Headed Cannulated Screws are implants used for the physical fixation of bone fractures and fragments within the body. They are a surgical device, not a diagnostic tool that analyzes biological samples.
- Intended Use: The intended use clearly describes surgical procedures for bone fixation, not diagnostic testing.
- Device Description: The description details the physical characteristics of screws and washers made from titanium alloy, which are materials used for implants, not diagnostic reagents or equipment.
Therefore, based on the provided information, the DARCO® Headed Cannulated Screws are a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DARCO® Headed Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. Wright Medical's washers may be used with the screws in cases where the patient has poor bone quality.
- Minimally invasive fracture / joint reconstructions .
- Multiple- fragment joint fractures ●
- Simple metaphyseal fractures .
- Simple epiphyseal fractures .
- Fractures of the head of the humerus o
- Fractures of the head of the tibia o
- Cooper fractures of the tibia O
- Fractures of the radius o
- Fractures of the wrist, ankle, elbow and shoulder .
- Scaphoid fractures and other fractures of the hand ●
- Metatarsal fractures and other fractures of the foot .
- Ligament fixation of the proximal humerus .
- Ligament avulsion injuries (Apohysis) ●
- Fractures of small joint bones ●
- Malleolar fractures o
- Navicular fractures o
- . Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint .
- Avulsion fracture and metatarsal V .
- Fractures of the tarsal region .
Product codes
HWC
Device Description
The DARCO® Headed Cannulated Screws will be offered in various sizes, thread types, The screws contain an optional washer will be made available with the and lengths. system. The screws and washers are manufactured from titanium alloy.
The design features of the DARCO ® Headed Cannulated Screws are substantially equivalent to the design features of other devices previously cleared for market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
N/A
Description of the test set, sample size, data source, and annotation protocol
N/A
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was shown through the full characterization of the subject and predicate screws and the use of available complaint data.
The safety and effectiveness of the DARCO® Headed Cannulated Screws is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
JUN 2 4 2010
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the DARCO® Headed Cannulated Screws.
| A.1. Submitted By: | Wright Medical Technology, Inc.
5677 Airline Rd
Arlington, TN 38002 |
|-----------------------------------|---------------------------------------------------------------------------|
| Date: | February 4, 2010 |
| Contact Person: | Kelsey Lee
Regulatory Affairs Specialist I
(901) 290-5909 |
| A.2. Proprietary Name: | DARCO® Headed Cannulated Screws |
| Common Name: | Cannulated Bone Screw |
| Device Classification Regulation: | 21 CFR 888.3040--Class II |
| Device Product Code & Panel: | HWC: Screw, Fixation, Bone |
| A.3. Predicate Device: | aap Cannulated Screws (K080101) |
A.4. Device Description
The DARCO® Headed Cannulated Screws will be offered in various sizes, thread types, The screws contain an optional washer will be made available with the and lengths. system. The screws and washers are manufactured from titanium alloy.
The design features of the DARCO ® Headed Cannulated Screws are substantially equivalent to the design features of other devices previously cleared for market.
A.5. Intended Use
The DARCO® Headed Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. Wright Medical's washers may be used with the screws in cases where the patient has poor bone quality.
- Minimally invasive fracture / joint reconstructions .
- Multiple- fragment joint fractures ●
- Simple metaphyseal fractures .
- Simple epiphyseal fractures .
- Fractures of the head of the humerus o
- Fractures of the head of the tibia o
- Cooper fractures of the tibia O
- Fractures of the radius o
1
K100359 p. Zot 2
- Fractures of the wrist, ankle, elbow and shoulder .
- Scaphoid fractures and other fractures of the hand ●
- Metatarsal fractures and other fractures of the foot .
- Ligament fixation of the proximal humerus .
- Ligament avulsion injuries (Apohysis) ●
- Fractures of small joint bones ●
- Malleolar fractures o
- Navicular fractures o
- . Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint .
- Avulsion fracture and metatarsal V .
- Fractures of the tarsal region .
The indications are limited in scope when compared to the legally marketed predicate device. Wright Medical Technology, Inc. has chosen to limit the indications to focus on the market in which the subject device is being promoted.
A.6. Technological Characteristics Comparison
The subject DARCO® Headed Cannulated Screws and the predicate aap Cannulated Screws have the following similarities: Materials, Diameters, Thread Types, Lengths, and Indications.
B.1. Substantial Equivalence - Non-Clinical Evidence
Substantial equivalence was shown through the full characterization of the subject and predicate screws and the use of available complaint data.
The safety and effectiveness of the DARCO® Headed Cannulated Screws is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within the Premarket Notification.
B.2. Substantial Equivalence - Clinical Evidence
N/A
B.3. Substantial Equivalence - Conclusions
Substantial equivalence is shown through the characterization of the subject and predicate screws and the available complaint data. The materials, diameters, lengths, thread types and indications are similar and there are no substantial differences between the subject and predicate. From the evidence given in the Premarket Notification, the subject screws can be expected to perform at least as well as the predicate screws.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation, resembling a bird-like shape. The profiles are rendered in black. Encircling the graphic is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", arranged in a circular fashion around the graphic. The text is also in black.
JUN 2 4 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Wright Medical Technology, Inc. c/o Ms. Kelsey Lee Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002
Re: K100359
Trade/Device Name: Darco® Headed Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 9, 2010 Received: June 10, 2010
Dear Ms. Lee,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: DARCO® Headed Cannulated Screws
Indications For Use:
The DARCO® Headed Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. Wright Medical's washers may be used with the screws in cases where the patient has poor bone quality.
- Minimally invasive fracture / joint reconstructions .
- Multiple- fragment joint fractures ●
- Simple metaphyseal fractures .
- Simple epiphyseal fractures .
- Fractures of the head of the humerus
- Fractures of the head of the tibia o
- Cooper fractures of the tibia o
- o Fractures of the radius
Fractures of the wrist, ankle, elbow and shoulder �
- Scaphoid fractures and other fractures of the hand .
- Metatarsal fractures and other fractures of the foot .
- Ligament fixation of the proximal humerus .
- Ligament avulsion injuries (Apohysis) ●
- Fractures of small joint bones .
- o Malleolar fractures
- o Navicular fractures
- Fractures of the calcaneus and talus .
- Arthrodesis of the ankle joint .
- Avulsion fracture and metatarsal V .
- Fractures of the tarsal region
× Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
| 1 of 1 | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| (Division Sign-Off) for mxm | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K100359 |